A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI) (NEON)

September 10, 2012 updated by: AstraZeneca

An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research site
  • Chile
      • Santiago de Chile, Chile
        • Research site
      • Temuco, Chile
        • Research site
      • Vina del Mar, Chile
        • Research site
  • Colombia
      • Barranquilla, Colombia
        • Research site
      • Bogota, Colombia
        • Research site
      • Medellin, Colombia
        • Research site
  • Venezuela
      • Barquisimeto, Venezuela
        • Research site
      • Caracas, Venezuela
        • Research site
      • San Cristobal, Venezuela
        • Research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
  • informed consent
  • over 18 years of age

Exclusion Criteria:

  • Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
  • More than 1 other course of PPI treatment in the previous 12 month
  • previous use of esomeprazole
  • presence of alarm symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nexium 40 mgs
Drug: Esomeprazole 40 mg
Once a day
Other Names:
  • Nexium
Procedure: Physical Exam
every visit
Other: Quality of Life Questionnaires
every visit
Procedure: pregnancy test, if applicable
as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Time Frame: At Baseline and 8 weeks
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
At Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Time Frame: At Baseline and 4 weeks
Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
At Baseline and 4 weeks
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Time Frame: At Baseline and 8 weeks

Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 8 weeks
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Time Frame: At Baseline and 4 weeks

Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 4 weeks
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Time Frame: At Baseline and 4 weeks.

Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.

Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 4 weeks.
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Time Frame: At Baseline and 8 weeks.

Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.

Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 8 weeks.
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Time Frame: At Baseline and 4 weeks

Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.

Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 4 weeks
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Time Frame: At Baseline and 8 weeks

Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.

Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Time Frame: At Baseline and 8 weeks

Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 8 weeks
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Time Frame: At Baseline and 4 weeks

Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 4 weeks
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Time Frame: At Baseline and 8 weeks

Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 8 weeks
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Time Frame: At Baseline and 4 weeks

Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".

Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
At Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (Estimate)

August 13, 2008

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612L00116
  • NEON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux Disease

Clinical Trials on Esomeprazole 40 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe